Pulmicort Respules(budesonide inhalation suspension) vs Singulair, children

Study identifier:DX-RES-2103

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An evaluation of the effectiveness of Pulmicort Respules (Budesonide inhalation Suspension) versus SINGULAIR (montelukast sodium) in children 2-8 years old with asthma requiring controller therapy.

Medical condition

asthma

Phase

Phase 4

Healthy volunteers

Study drug

Budesonide inhalation suspension, Montelukast Sodium

Sex

All

Actual Enrollment

380

Study type

Interventional

Age

2 Years - 8 Years

Date

Study Start Date: 01 Oct 2002

Primary Completion Date: 01 Feb 2005

Study Completion Date: 01 Feb 2005

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1 Budesonide inhalation suspension	Drug: Budesonide inhalation suspension 0.5mg Other Name: Pulmicort Respules
Active Comparator: 2 Montelukast sodium	Drug: Montelukast Sodium 4mg or 5mg Other Name: SINGULAR

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=731&filename=CSR-DX-RES-2103.pdf
Download
CSR-DX-RES-2103.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

null AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Bertil Andersson

AstraZeneca